Continuous infusion of monoclonal antibody‐purified factor VIII

Weinstein, Ralph E.; Bona, Robert; Rickles, Frederick R.

doi:10.1002/ajh.2830360311

Cited by 31 publications

(25 citation statements)

References 8 publications

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“…Only very limited observations on the stability of immunoaffinity-purified F VIII (Monoclate) for 12 hr after reconstitution [7] and on fibrinogen in thawed cryoprecipitate at 1 4°C for 1 month [8] have previously been published. In a recent report, the stability of Octaliquid at 4°C for 5 months and at 37°C for 2 weeks was also mentioned [9].…”

Section: Discussionmentioning

confidence: 99%

“…In this context it is of paramount importance to assess the stability of the concentrate after reconstitution. Only limited data on this topic have been published previously [7]. The manufacturers have usually performed stability tests before and after reconstitution and at different temperatures, but the recommendations are to use the concentrate immediately or within 1 or 3 hr after reconstitution, depending on the concentrate.…”

Section: Introductionmentioning

confidence: 99%

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Stability of factor VIII concentrates after reconstitution

1994

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Adjusted-dose continuous infusion of factor VIII (F VIII) has recently been shown to reduce the doses of the factor in patients undergoing surgery by 50-75%. The main limitation of this method has been the instability of factor concentrates. All manufacturers are recommending infusion of the concentrate within hours after reconstitution. We studied the stability of 15 different lyophilized F VIII products. Reconstituted samples were stored for periods of 4, 24, and 72 hr and 1, 2, 3, and 4 weeks at temperatures of 4-8 degrees C, 20-23 degrees C, and 37 degrees C in their original glass containers and in plastic tubes and then frozen. Assays were performed in duplicate, using a one-stage clotting method and a chromogenic assay for F VIII, with all samples from a single concentrate in the same run. Activation of the coagulation factor occurred in some concentrates, more often at 4-8 degrees C than at 20-23 degrees C or 37 degrees C. The stability of all products was substantially better than that declared by the manufacturers. Several concentrates maintained factor activities above 80% of baseline for the entire period of 4 weeks at 4-8 degrees C or at 20-23 degrees C. The results demonstrate that many of the F VIII concentrates may be used for continuous infusion.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Stability of factor VIII concentrates after reconstitution

1994

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“…Continuous infusion therapy has been suggested to maintain a steady plasma level of FVIII activity above that at which there is a risk of bleeding. Although continuous infusion has been shown to be safe, effective, and practical [ 1–6], it is not widely used, and clinical experience is still lacking with some FVIII concentrates.…”

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confidence: 99%

Continuous infusion of intermediate‐purity factor VIII in haemophilia A patients undergoing elective surgery

et al. 1999

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An open, non-randomized trial of continuous infusion therapy was conducted involving five patients with severe haemophilia A who required factor VIII (FVIII) prophylaxis for elective surgery. This was preceded by a 24-h preoperative pharmacokinetic study to characterize the pharmacokinetic parameters of each individual patient following a bolus dose of the intermediate-purity product. A retrospective matched control group was identified to allow for comparisons of FVIII usage between bolus and continuous infusion administration. A loading dose of FVIII was administered preoperatively, and the continuous infusion was started at the end of surgery and continued for 5 days. The patients' FVIII levels, vital signs, and infusion sites were monitored on a daily basis. The clearance was re-calculated on a daily basis using the FVIII activity of that day to adjust the infusion rate to achieve the desired FVIII level. The mean (CV%) pharmacokinetic parameters estimated preoperatively by noncompartmental analysis were: clearance 3.2 mL kg-1 h-1 (35.5%), volume of distribution 52.1 mL kg-1 (40.2%), mean residence time 17.4 h (23.3%), and half-life 12.7 h (23.6%). A progressive decrease in the clearance of FVIII from a mean of 3.1 mL kg-1 h-1 to 2.0 mL kg-1 h-1 (P = 0.125) over the first 5 days was observed. A therapeutically acceptable level of FVIII was systematically achieved, with the only complication being frequent thrombophlebitis. On average the patients used 19% less FVIII when compared with matched historical controls (P = 0.25). This method was found to be safe and effective in haemophilia A patients undergoing elective surgery procedures.

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“…In boys with haemophilia carrying CVADs, asymptomatic thrombosis has been described by angiographic assessment in as much as 37% and 61% of patients with the median duration of catheter placement 6.4 and 4.75 years [17,18]. Studies have even indicated that heparin may interfere with factor concentrate stability [20], although this has not been demonstrated for LMWH specifically [21]. In order to prevent CI-related thrombosis, some authors propose adding small amounts of low-molecular weight heparin (LMWH) to the factor concentrate [7].…”

Section: Discussionmentioning

confidence: 99%